SHANGHAI, China & JERSEY CITY, N.J., April 29, 2026
Shanghai Henlius Biotech, Inc. and Organon have announced that the European Commission (EC) has granted marketing authorization for POHERDY® (pertuzumab), the first and only approved biosimilar to PERJETA® (pertuzumab) in Europe, for all indications of the reference product. This major regulatory milestone significantly expands treatment access for patients with HER2-positive breast cancer across Europe while strengthening the role of biosimilars in improving healthcare affordability and sustainability.
First Pertuzumab Biosimilar Approved in Europe
The EC approval of POHERDY® 420 mg/14 mL injection for intravenous use marks a major advancement in the European oncology biosimilars market. As the first approved biosimilar to Roche’s PERJETA®, POHERDY creates a new opportunity to improve access to life-saving targeted therapies for patients with aggressive HER2-positive breast cancers.
Breast cancer remains the most commonly diagnosed cancer among women and one of the leading causes of cancer-related deaths across the European Union. The availability of the first pertuzumab biosimilar is expected to reduce treatment barriers by improving affordability while supporting broader healthcare system sustainability. Organon emphasized that expanding its biosimilar portfolio aligns with its long-term strategy of improving women’s health through access to high-quality medicines.
Broad Indications for HER2-Positive Breast Cancer Treatment
Advertisement
In Europe, POHERDY is approved in combination with trastuzumab and docetaxel for adults with HER2-positive metastatic or locally recurrent unresectable breast cancer who have not previously received anti-HER2 therapy or chemotherapy for metastatic disease.
Additionally, POHERDY is indicated with trastuzumab and chemotherapy for both neoadjuvant treatment of adults with HER2-positive locally advanced, inflammatory, or early-stage breast cancer at high risk of recurrence, and adjuvant treatment for adults with HER2-positive early breast cancer at high risk of recurrence. These broad indications allow POHERDY to support treatment across multiple stages of breast cancer management, from early intervention to advanced metastatic disease.
Strong Clinical Evidence and Global Commercial Expansion
The EC approval was supported by a comprehensive package of evidence, including structural and functional analytical data, clinical pharmacokinetics, comparative efficacy studies, safety analysis, and immunogenicity evaluation, confirming that POHERDY is highly similar to the reference biologic. This totality-of-evidence approach is critical for biosimilar regulatory approvals and reinforces confidence among clinicians and healthcare systems.
The approval also builds on POHERDY’s earlier FDA approval in the United States, where it became the country’s first pertuzumab biosimilar. In 2022, Henlius and Organon entered into a strategic licensing and supply agreement granting Organon exclusive global commercialization rights for several biosimilars, including POHERDY, outside China.
This latest EC authorization further strengthens both companies’ global biosimilar leadership and supports faster access to advanced cancer treatments worldwide. As demand for cost-effective oncology therapies continues to grow, POHERDY is positioned to play a major role in improving treatment access and supporting more sustainable cancer care systems across Europe.
Source: Henlius press release
